Attorneys for Plaintiff, Annette Weil and the Putative Classes UNITED STATES DISTRICT COURT CENTRAL DISTRICT OF CALIFORNIA

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1 Case :-cv-00 Document Filed 0/0/ Page of Page ID #: Meiram Bendat (Cal. Bar No. ) PSYCH-APPEAL, INC. 0 West Sunset Boulevard, Suite 00 West Hollywood, CA 00 Tel: () -0, x. Fax: () -000 mbendat@psych-appeal.com D. Brian Hufford (pro hac vice forthcoming) Jason S. Cowart (pro hac vice forthcoming) ZUCKERMAN SPAEDER LLP Park Avenue, th Floor New York, NY 0 Tel: () 0-00 Fax: () 0- dbhufford@zuckerman.com jcowart@zuckerman.com Attorneys for Plaintiff, Annette Weil and the Putative Classes [Additional counsel appear on signature page] ANNETTE WEIL, on her own behalf and on behalf of all others similarly situated, v. UNITED STATES DISTRICT COURT CENTRAL DISTRICT OF CALIFORNIA Plaintiff, CIGNA HEALTH AND LIFE INSURANCE COMPANY, CIGNA HEALTH MANAGEMENT, INC., CIGNA BEHAVIORAL HEALTH, INC., and MCMC, LLC, Defendants. Case No. :-cv-0 CLASS ACTION COMPLAINT 00.

2 Case :-cv-00 Document Filed 0/0/ Page of Page ID #: Plaintiff Annette Weil ( Plaintiff ), complains as follows on her own behalf and on behalf of all others similarly situated, against Defendants Cigna Health and Life Insurance Company, Cigna Health Management, Inc., Cigna Behavioral Health, Inc. (collectively Cigna ), and MCMC, LLC ( MCMC and, collectively with Cigna, Defendants ). INTRODUCTION. Plaintiff is a -year old beneficiary of the Starz Health and Welfare Plan (the Weil Plan ), a group health benefit plan sponsored by the private-sector employer of Plaintiff s husband. The Weil Plan is governed by the Employee Retirement Income Security Act ( ERISA ), U.S.C. 0, et seq., and is administered by Cigna.. Plaintiff suffers from Major Depressive Disorder, which has not been alleviated by psychotherapy, numerous administrations of anti-depressant medications, and Electro-Convulsive Therapy ( ECT ). In October, Plaintiff s treating mental health care providers recommended that Plaintiff undergo therapeutic repetitive Transcranial Magnetic Stimulation ( TMS or rtms ) therapy. Cigna, however, denied Plaintiff s request for pre-authorization for TMS therapy based on a medical policy that it created ( TMS Policy ), which analyzes TMS therapy and concludes that it is not covered by Cigna Plans because those plans all contain an exclusion for experimental/investigational/unproven 00.

3 Case :-cv-00 Document Filed 0/0/ Page of Page ID #: services (the E/I Exclusion ). Thereafter, Plaintiff proceeded to obtain TMS therapy, with tremendous results, and submitted TMS-related claims to Cigna.. Upon receipt of Plaintiff s TMS claims, Cigna continued to deny tens of thousands of dollars in benefits. Following Cigna s preauthorization and claims denials, Plaintiff exhausted all internal appeals provided by the Plan. Cigna responded to each level of appeal by upholding the denial of coverage based solely on its TMS Policy and the E/I Exclusion, and without considering the substantial materials submitted by Plaintiff and her providers supporting coverage for TMS. Thereafter, Plaintiff filed an external appeal with MCMC, a so-called Independent Review Organization ( IRO ), which upheld the denial on the same basis.. In denying coverage, Cigna followed its uniform TMS Policy, that mandates denial of coverage for TMS therapy for all Cigna-administered plans. In turn, MCMC rubber-stamped Cigna s denial based on a perfunctory review by an anonymous child psychiatrist who lacked direct experience with TMS and who referenced outdated literature while ignoring a body of contemporary, peerreviewed, published evidence for TMS as a safe and effective treatment for Major Depressive Disorder. Neither Cigna nor MCMC properly applied the E/I Exclusion found in the Weil Plan.. TMS is a non-invasive procedure that uses an electromagnet to generate repeated pulsed magnetic fields that stimulate nerve cells in the region of 00.

4 Case :-cv-00 Document Filed 0/0/ Page of Page ID #: the brain associated with mood control, thereby improving symptoms of depression. Unlike electroconvulsive therapy ( ECT ) sometimes known as electro-shock therapy in which an outside electric current is applied to the brain via electrodes, TMS only induces electrical activity within the brain, and does not cause seizures or the related side effects.. There is overwhelming evidence that TMS is safe and effective and is a generally accepted standard of medical practice for the treatment of depression within the mental health community: TMS has been around and well-accepted for over years; the Food and Drug Administration ( FDA ) has approved TMS for Major Depressive Disorder; the American Psychiatric Association and other nationally-recognized medical organizations, and numerous meticulous peerreviewed studies have validated the safety and effectiveness of TMS; hundreds of respected mental health facilities and providers, including UCLA, the Harvard Medical System, Boston Medical Center, Johns Hopkins University, Cornell University, Boston University, and Brown University, recommend and use TMS on a regular basis; and many insurers, including Medicare, UnitedHealthcare, Anthem, Health Care Service Corporation, and nearly independent Blue Cross/Blue Shields have recognized that TMS is a safe and effective treatment for refractory Major Depressive Disorder and that it is not experimental. 00.

5 Case :-cv-00 Document Filed 0/0/ Page of Page ID #:. TMS therapy is, therefore, a proven, efficacious treatment for depression, and is not experimental or investigational by any fair definition of those terms, and certainly not within the meaning of those terms as defined in the Weil Plan or in similar Cigna-administered plans. Cigna s TMS Policy, and Defendants resulting denial of TMS coverage for Plaintiff and members of the Classes she seeks to represent (as defined below), violated the terms of the relevant plans and Defendants fiduciary obligations under ERISA.. Under ERISA, Plaintiff and the members of the Classes are entitled to equitable and declaratory relief enjoining application of Cigna s erroneous medical policy, reversing Defendants benefits denials of coverage for TMS therapy, and awarding such other relief as the Court finds appropriate. THE PARTIES. Plaintiff resides in Malibu, California.. Defendant Cigna Health and Life Insurance Company is a Connecticut corporation headquartered at 00 Cottage Grove Road, Bloomfield, Connecticut 000. Defendant Cigna Health Management, Inc. is a Delaware corporation headquartered at 0 Chestnut Street, Philadelphia, Pennsylvania. Defendant Cigna Behavioral Health, Inc. is a Minnesota corporation headquartered at 0 Viking Drive, Suite 0, Eden Prairie, Minnesota. All these entities are registered with the California Secretary of State to do 00.

6 Case :-cv-00 Document Filed 0/0/ Page of Page ID #: business in California. According to URAC, a national utilization review accrediting organization, Defendant Cigna Health Management, Inc., is accredited for Health Utilization Management at 00 North Brand Boulevard, Suite 00, in Glendale, California. In the letters issued by Cigna to Plaintiff denying coverage for TMS treatments, Cigna explains that Cigna Behavioral Health, Inc., a licensed utilization review agent, reviews certain health care services for medical necessity for Cigna Health and Life Insurance Company.. Defendant MCMC is a Delaware limited liability managed care services company headquartered at 00 Crown Colony Drive, Suite, Quincy, Massachusetts 0. It operates a primary processing center in Rancho Cucamonga, California and is registered with the California Secretary of State to do business in California. Among other things, MCMC directly contracts with Cigna and other insurers to serve as an IRO to adjudicate external appeals pursued by Cigna insureds or their providers. JURISDICTION AND VENUE. Defendants actions in administering employer-sponsored health care plans, making coverage and benefit determinations under the terms and conditions of the health care plans, and/or processing appeals of coverage and benefit determinations under the terms and conditions of the health care plans are 00.

7 Case :-cv-00 Document Filed 0/0/ Page of Page ID #: governed by ERISA. This Court has jurisdiction of this case under U.S.C. (federal question jurisdiction) and U.S.C. (e) (ERISA).. Venue is appropriate in this District because Plaintiff and her treating providers reside here and the TMS treatment at issue was offered and provided here. Additionally, Defendants conduct significant operations in this District and are registered with the California Secretary of State to do so. FACTUAL ALLEGATIONS. The majority of the health plans underwritten and/or administered by Cigna, including the Weil Plan, are employee welfare benefit plans sponsored by private-sector employers governed by ERISA ( ERISA plans ).. During all relevant times, Cigna acted as a fiduciary with respect to its administration of ERISA plans. In particular, Cigna interpreted and applied ERISA plan terms, made coverage and benefit decisions under the ERISA plans within its sole discretion, and provided payment under the ERISA plans to participants/beneficiaries and their providers. Accordingly, Cigna was required to comply with the requirements ERISA imposes on fiduciaries.. In serving in the capacity of an IRO for external appeals from Cigna s coverage and benefit decisions under the ERISA plans, MCMC also acted as an ERISA fiduciary, in that it was vested with discretion to make final benefit determinations as to such external appeals. In that capacity, MCMC was also 00.

8 Case :-cv-00 Document Filed 0/0/ Page of Page ID #: responsible for interpreting and applying ERISA plan terms, making coverage and benefit decisions, and authorizing payments to participants/beneficiaries and their providers. In fulfilling this responsibility, MCMC therefore was required to comply with the requirements ERISA imposes on fiduciaries.. The health insurance plans administered by Cigna are either fullyinsured or self-funded. With respect to fully-insured plans, Cigna both administers the plan by making all benefit determinations and pays the benefits out of its own assets. With respect to self-funded plans, Cigna administers the plan, but the underlying plan sponsor or employer through which the insurance is provided is ultimately responsible for reimbursing Cigna for the benefit payments.. When processing benefits for a self-funded plan, Cigna makes all benefit determinations and authorizes benefit checks to be issued out of bank accounts which Cigna controls. Periodically, Cigna will notify the sponsors of the self-funded plans of the need to replenish their accounts so that benefits can be paid. But Cigna nevertheless continues to control these accounts and is fully responsible for processing the insurance claims and making the determination whether to issue the check from these accounts.. Thus, irrespective of whether a particular ERISA plan is fully-insured or self-funded, Cigna is the proper party for Plaintiff, and the putative class, to sue because Cigna not the underlying plan sponsor or employer made all the 00.

9 Case :-cv-00 Document Filed 0/0/ Page of Page ID #: relevant decisions and wielded the authority to issue benefit checks under the ERISA plans.. The only exception to Cigna s control over benefit determinations is a situation in which Cigna denies a claim and the relevant insured elects to pursue an external appeal with an IRO. In this situation, Cigna agrees to comply with the decision of the IRO (which it self-selects and with which it directly contracts), such as MCMC, but only with regard to the specific decision from which the appeal was taken. As a result, even if an IRO disagrees with a particular Cigna medical policy and approves coverage for a specific claim, Cigna will continue to apply its medical policy going forward with regard to similar claims. The Weil Plan. The Weil Plan is a self-funded plan, meaning that the plan sponsor, Starz, is responsible for reimbursing Cigna for the benefit payments. However, Cigna maintains control over the decision-making process and is ultimately responsible for authorizing the issuance of checks for paying benefits.. The Weil Plan reimburses Plaintiff or her treating providers for Covered Services, which is defined as the expenses incurred by or on behalf of a person for the specified charges, including charges made by a Physician or a Psychologist for professional services. Among other things, the Weil Plan covers Mental Health Services, defined as services that are required to treat a disorder 00.

10 Case :-cv-00 Document Filed 0/0/ Page of Page ID #: that impairs the behavior, emotional reaction or thought processes, including Outpatient Mental Health Services. Covered Outpatient Mental Health Services include, but are not limited to, outpatient treatment of conditions such as: anxiety or depression which interfere with daily functioning [and] emotional adjustment or concerns related to chronic conditions, such as psychosis or depression.... The Weil Plan includes a list of exclusions, which is a list of services specifically excluded from Mental Health and Substance Abuse Services. TMS is not part of the exclusion list, nor do any of the enumerated exclusion categories relate to or include TMS treatment. In addition, the Weil Plan has a separate category of Exclusions, Expenses Not Covered and General Limitations, which includes a list of services which are specifically excluded from this plan, including experimental, investigational or unproven services. These are defined as follows: Experimental, investigational and unproven services are medical, surgical, diagnostic, psychiatric, substance abuse or other health care technologies, supplies, treatments, procedures, drug therapies or devices that are determined by the utilization review Physician to be: not demonstrated, through existing peer-reviewed, evidence-based, scientific literature to be safe and effective for treating or diagnosing the condition or sickness for which its use is proposed; not approved by the U.S. Food and Drug Administration (FDA) or other appropriate regulatory agency to be lawfully marketed for the proposed use; the subject of review or approval by an Institutional Review Board for the proposed use except as provided in the Clinical Trials section of 00.

11 Case :-cv-00 Document Filed 0/0/ Page of Page ID #: this plan; or the subject of an ongoing phase I, II or III clinical trial, except as provided in the Clinical Trials Section of this plan.. The last two criteria under the E/I Exclusion, relating to an Institutional Review Board or clinical trials, are not relevant to TMS therapy systems. TMS therapy is not subject to other institutional approval before it can be used. It is similarly not the subject of an ongoing Phase I, II or III clinical trial. Thus only the first two criteria, relating to FDA approval, and peer-reviewed, evidence-based, scientific literature bear on whether or not the E/I Exclusion applies.. In October 0, the FDA approved TMS therapy systems, designating them as a Class II Device for the treatment of Major Depressive Disorder. This classification was codified at C.F.R..0, and describes TMS as an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder without inducing seizure in patients.. There is a wealth of peer-reviewed, evidence-based, scientific literature that demonstrate[s] TMS to be safe and effective for treating Major Depressive Disorder. For example, the American Psychiatric Association Practice Guideline for the Treatment of Patients With Major Depressive Disorder 00.

12 Case :-cv-00 Document Filed 0/0/ Page of Page ID #: lists TMS as a valid treatment option for refractory depression, a Psychological Medicine meta-analysis of the literature from - on MEDLINE, EMBASE, PsycINFO, Cochrane Central Register of Controlled Trials, SCOPUS, and ProQuest Dissertations & Theses concluded that TMS seems to be associated with clinically relevant antidepressant effects and with a benign tolerability profile, and a Clinical Neurophysiology article authored by the leading researchers in the field established the definite efficacy of TMS for the treatment of depression. Weil Plan.. Thus, TMS therapy systems do not fit within the E/I Exclusion to the. In addition to the E/I Exclusion, the Weil Plan has a section entitled General Limitations. This specifies, inter alia, that [n]o payment will be made for... expenses for supplies, care, treatment, or surgery that are not Medically Necessary, which is defined as follows: Medically Necessary/Medical Necessity Medically Necessary Covered Services and Supplies are those determined by the Medical Director to be: required to diagnose or treat an illness, injury, disease or its symptoms; in accordance with generally accepted standards of medical practice; clinically appropriate in terms of type, frequency, extent, site and duration; not primarily for the convenience of the patient, Physician or 00.

13 Case :-cv-00 Document Filed 0/0/ Page of Page ID #: other health care provider; and rendered in the least intensive setting that is appropriate for the delivery of the services and supplies. Where applicable, the Medical Director may compare the cost-effectiveness of alternative services, settings or supplies when determining least intensive setting.. The denials at issue in this case relate to Cigna s E/I Exclusion. In applying this policy, Defendants did not make a Medical Necessity determination, but only determined that TMS is not covered as experimental, investigational or unproven. Defendants Denial of Coverage for Plaintiff s TMS Therapy 0. Plaintiff has been in treatment for chronic depression diagnosed as Major Depressive Disorder for over years. She has obtained extensive outpatient therapy, without success, and has tried and failed numerous antidepressant medications, including Prozac, Abilify, Saphris, Seroquel, Zyprexa, Cymbalta, Effexor, Emsam, Lexapro, Paxil, Pristiq, Vivactil, Zoloft and Lamictal. Plaintiff did not positively respond to any of these treatments for any sustained period of time. In addition, Plaintiff underwent sessions of ECT in, which were similarly ineffective over time, while also causing undesirable neurocognitive side effects, including memory loss.. Accordingly, in October, Plaintiff s treating providers recommended that she receive TMS therapy. 00.

14 Case :-cv-00 Document Filed 0/0/ Page of Page ID #:. Although the Weil Plan did not require Plaintiff to receive preauthorization from Cigna for TMS, her provider nonetheless sought preauthorization, as provided for by ERISA, before Plaintiff incurred the expense.. By letter dated October,, Dr. William F. Stubbeman, a boardcertified psychiatrist specializing in TMS therapy for Major Depressive Disorder, wrote to Cigna to obtain pre-certification for coverage. He explained that, [h]aving exhausted all other available treatment options, Plaintiff had been referred to his office for TMS treatment by her treating psychiatrist, Dr. Harvey Sternbach, a Distinguished Life Fellow of the American Psychiatric Association, and sought to begin TMS therapy on October,. Dr. Stubbeman stated: After ruling out all contraindications, I have recommended TMS as it is the only alternative to all the failed medications, ECT and [other] evidenced-based therapies. He further explained: As a certified TMS psychiatrist who has trained with the most prominent TMS physicians in the country including Dr. Sarah H. Lisanby at Duke and Dr. Alvaro Pascual-Leone at Harvard, and administered the most TMS treatments in the country just a few years ago, I have treated numerous patients who had similar psychiatric histories. TMS has been the only treatment that not only brings their depression into remission, but also has lasting results. I have treated patients who are now over three years out of TMS treatment, and they continue not only to maintain remission, but lead happy, productive lives. I ask, on behalf of my patient, that you provide coverage for this medically necessary treatment. 00.

15 Case :-cv-00 Document Filed 0/0/ Page of Page ID #:. By letter dated October,, Defendant Cigna Health Management, Inc., responded to Dr. Stubbeman s letter by denying coverage for Plaintiff s TMS treatments, stating: Based upon current available information, coverage cannot be approved because there is not enough scientific evidence that shows the safety and/or effectiveness of transcranial magnetic stimulation (TMS) for any indication including Major Depressive Disorder. At the present time, it is considered non-standard therapy and falls under the category of experimental/investigational/unproven. Your benefit plan does not cover experimental/investigational/unproven services. The letter added that the decision not to cover TMS was made by Dr. John Granato, Jr. on behalf of Cigna. No information was given concerning Dr. Granato s training or experience, including any knowledge or experience relating to TMS. Plaintiff s investigation has revealed that Dr. Granato is a -year-old urologist. Based on information and belief, he has no independent knowledge of or experience with providing TMS or treating Major Depressive Disorder. Dr. Granato has previously received negative publicity for denials of coverage on behalf of Cigna. See In denying coverage for TMS, Cigna failed to discuss the many studies which demonstrate the safety and effectiveness of TMS, or its widespread use by well-recognized, leading mental health providers.. Plaintiff obtained the TMS treatments on the advice and recommendation of her treating providers. By letter dated January,, 00.

16 Case :-cv-00 Document Filed 0/0/ Page of Page ID #: Plaintiff s treating psychiatrist, Dr. Sternbach, appealed Cigna s coverage denial on Plaintiff s behalf. In his appeal letter, Dr. Sternbach explained that Plaintiff had begun TMS treatment with Dr. Stubbeman [d]ue to unremitting depression, adding that she has had improvement of depression and we hope to continue treatment and avoid a relapse with risk of suicide.. In support of his appeal, Dr. Sternbach enclosed a June summary of the Institute for Clinical and Economic Review ( ICER ), a leading academic comparative effectiveness research group based at the Massachusetts General Hospital s Institute for Technology Assessment, entitled Coverage Policy Analysis. Repetitive TMS. In this article, ICER reported that in December, the New England Comparative Effectiveness Public Advisory Council ( CEPAC ) had reviewed the [Agency for Healthcare Research and Quality ( AHRQ )] evidence review on rtms along with supplemental information on utilization, costs, and cost-effectiveness, and had voted that the evidence was adequate to demonstrate that (rtms) was as good as or better than usual care for patients with treatment-resistant depression.. Dr. Sternbach further enclosed a copy of the medical policy covering TMS for Blue Cross Blue Shield of Kansas, effective October, along with [a]bstracts of articles (out of many in the literature) regarding the effectiveness of TMS. He then concluded: 00.

17 Case :-cv-00 Document Filed 0/0/ Page of Page ID #: In summary, TMS is not investigational treatment, is being used all over the world to treat depression, including pharmacotherapyresistant depression, and as such, is a necessary and potentially lifesaving treatment for patients with depression. In the case of my patient, Annette Weil, TMS has been beneficial and Cigna s policy to deny this treatment should be reviewed and overturned based upon the patient s response and the scientific literature. The Institute for Clinical and Economic Review analysis was funded by the Agency for Healthcare Research and Quality and, as such, is an objective review of this treatment. Cigna s policy is, in my opinion, one that is outdated and potentially discriminatory.. By letter dated February,, Defendant Cigna Behavioral Health, Inc., out of its offices in Eden Prairie, Minnesota, issued a denial of the appeal, stating: Cigna Behavioral Health, Inc., a licensed utilization review agent, reviews certain health care services for medical necessity for Cigna Health and Life Insurance Company.... After a review of the information submitted and the terms of your benefit plan, we have decided to uphold the original decision not to authorize the requested services. Cigna s Peer Reviewer, Mohsin Qayyum, M.D. (TX: TN), a board certified psychiatrist, has determined that the requested services are not covered. The decision was based on the following: The clinical basis for this decision is: Authorization for Transcranial Magnetic Stimulation starting // cannot be justified. Your benefit is governed by policy 0 which considers this procedure to be one of a group that is considered investigational, experimental or unproven. This is therefore not considered to be reimbursable. Other clinically appropriate assessment and/or treatment interventions are covered under the medical necessity criteria for your benefit plan The letter added that [t]his coverage decision is not a treatment decision or a medical consultation, and that [i]f you choose to proceed with the 00.

18 Case :-cv-00 Document Filed 0/0/ Page of Page ID #: requested service(s), any claims associated with the denied request will not be considered for treatment. Although the Weil Plan actually provides for two levels of internal appeals, Cigna cemented its position on TMS by depriving Plaintiff of a second level internal appeal and misinforming her that [t]his decision represents the final step of the internal review process. Instead, Cigna stated to Plaintiff that she had the right to appeal the denial through an Independent Review Organization ( IRO ) or to pursue litigation in court under ERISA. Notably, Cigna s denial failed to acknowledge or address Dr. Sternbach s letter or the substantial evidence he submitted in support of TMS.. According to the website of the company that Dr. Qayyum works for, Progressive Behavioral Health, he is a Medical Director at Cigna with clinical experience in Adult Psychiatry, Forensic Psychiatry, Addiction Psychiatry, Consultation & Liaison Psychiatry, Neuropsychiatry, Geriatric Psychiatry and Occupational Psychiatry and is certified to perform Outpatient Narcotics Detoxification and Maintenance Treatment by using Buprenorphine. There is no indication that Dr. Qayyum has any knowledge of or experience with TMS. According to the Texas Medical Board, which licenses Dr. Qayyum, Dr. Qayyum has not reported any Awards, Honors, Publications and Academic Appointments. The California Medical Board website indicates that Dr. 00.

19 Case :-cv-00 Document Filed 0/0/ Page of Page ID #: Qayyum s License is in retired status and the licensee is exempt from payment of the renewal fee. No practice is permitted.. By letter dated April,, Plaintiff submitted a formal request to Cigna for an IRO Review of Cigna s denial of coverage for TMS treatment. Along with this request, Plaintiff included an updated letter from Dr. Stubbeman, referencing a recent article, published in the peer-reviewed journal, Clinical Neurophysiology, and authored by almost every leading researcher in the field, outlining significant clinical effects of TMS over numerous studies worldwide, and establishing Level A efficacy ( definite efficacy ) of TMS for the treatment of depression. Cigna referred the IRO Review to MCMC, a purported Independent Peer Review division servicing over 00 corporate clients.. MCMC denied Plaintiff s appeal by letter dated June,. In explaining the basis for its denial, MCMC stated: Review Question: Is the requested service a Plan/Benefit exclusion as defined by the Summary Plan Description? Yes. The requested service is a Plan/Benefit exclusion by way of being experimental/investigational. The requested service is experimental/investigational as per the definition in the Summary Plan Description. Experimental, investigational and unproven services include medical and psychiatric health care technologies, treatments, and procedures that determined to not have been demonstrated, through existing peer-reviewed, evidence-based, scientific literature to be safe and effective for treating or diagnosing the condition or sickness for which its use is proposed. 00.

20 Case :-cv-00 Document Filed 0/0/ Page of Page ID #: Plan: There is evidence from short term clinical trials that TMS can be beneficial. These results have not been adequately supported by long term studies to lead to net health benefits. Continued study is ongoing and required to determine appropriate clinical parameters, appropriate patient population, and appropriate clinical parameters including number of sessions and need for adjuvant treatment.. MCMC then quoted the purportedly applicable language in the Weil Per the Summary Plan Description: Experimental, investigational and unproven services are medical, surgical, diagnostic, psychiatric, substance abuse or other health care technologies, supplies, treatments, procedures, drug therapies or devices that are determined by the utilization review Physician to be: Not demonstrated, through existing peer-reviewed, evidence based, scientific literature to be safe and effective for treating or diagnosing the condition or sickness for which its use is proposed.... In support of its conclusion, MCMC cited to a series of outdated studies and did not reference any sources published in the past three years. Strikingly, while MCMC cited to a 0 ECT practice parameter by the American Psychiatric Association, it completely failed to reference the far more recent inclusion of TMS as a valid treatment option for refractory depression in the American Psychiatric Association Practice Guideline for the Treatment of Patients With Major Depressive Disorder.. In upholding Cigna s decision, MCMC failed to acknowledge, address or consider the detailed information submitted by Plaintiff and her providers, 00.

21 Case :-cv-00 Document Filed 0/0/ Page of Page ID #: including the amply referenced (and far more contemporaneous) studies regarding the safety and efficacy of TMS. Instead, MCMC merely rubber-stamped Cigna s position. MCMC s decision, like Cigna s, was without support or validity, arbitrary and capricious, and contrary to generally accepted standards of medical practice.. According to the MCMC letter, the reviewer who made the decision and identified only as Reviewer was board certified in Psychiatry with a sub-certification in Child and Adolescent Psychiatry. The anonymous reviewer s areas of expertise were generically described as including all psychiatric disorders, forensic psychiatry and child and adolescent psychiatry.. Nothing in this summary indicates that the reviewer had any direct training or experience with TMS or related treatments for Major Depressive Disorder, or with patients like Plaintiff who suffered from long-term depression resistant even to ECT. Notably, while the reviewer s primary area of expertise was related to child and adolescent psychiatry, TMS is not performed on children, and rarely performed on adolescents, and has been approved by the FDA solely for adults. MCMC therefore did not use a reviewer who was qualified to make a judgment about the safety and effectiveness of TMS therapy. 00.

22 Case :-cv-00 Document Filed 0/0/ Page of Page ID #: Defendants ERISA Violations. As the claims administrator responsible for interpreting and administering the Weil Plan, and similar Cigna plans issued nationwide, vested with responsibility for making final benefit determinations, Cigna is an ERISA fiduciary. 0. Similarly, when MCMC assumes the responsibility for making a final benefit determination as part of an external review, it also assumes responsibility for administering the Weil Plan and similar Cigna plans, and making benefit determinations thereunder. Thus, when acting in this capacity, MCMC is an ERISA fiduciary.. As ERISA fiduciaries, Defendants were required to discharge their duties consistent with U.S.C. Section 0, which requires (among other things) that they do so solely in the interest of the participants and beneficiaries and for the exclusive purpose of providing benefits to participants and their beneficiaries and paying reasonable expenses of administering the plan. They must do so with the care, skill, prudence, and diligence and in accordance with the terms of the plans they administer. Defendants violated all of these requirements.. Cigna violated these duties when it prepared and promulgated the TMS Policy, because Cigna relied upon outdated evidence, ignored evidence 00.

23 Case :-cv-00 Document Filed 0/0/ Page of Page ID #: indicating that TMS was not experimental, and unreasonably concluded that TMS was experimental, investigational or unproven. Cigna then compounded that breach of duty by relying upon the TMS Policy to deny insurance claims submitted by Plaintiff and members of the Class in contravention of the terms of their Cigna plans.. In doing so, Cigna elevated its own interests above the interests of plan participants and beneficiaries, reflecting its conflict of interest when determining whether to cover TMS. By promulgating and applying the TMS Policy, Cigna sacrificed the interests of insureds like Plaintiff so that it could artificially decrease the number and value of claims it was required to pay from its own assets (i.e., with respect to fully-insured plans and self-funded plans with stoploss provisions requiring Cigna to cover benefits above a certain threshold) and the assets of its employer-sponsor customers (i.e., with respect to other self-funded plans), moreover, by prioritizing the assets of its employer-sponsor customers, Cigna also advanced its own interests in retaining and expanding its business with such customers.. MCMC violated these duties when it similarly concluded that TMS Therapy was experimental based on outdated evidence and because it ignored evidence indicating that TMS was not experimental as defined by the terms of the Weil Plan and similar Cigna plans. 00.

24 Case :-cv-00 Document Filed 0/0/ Page of Page ID #:. MCMC has a self-serving motive to uphold Cigna s policies and coverage denials made pursuant to those policies, since Cigna decides whether it will continue to hire MCMC to review a large volume of appeals. As such, MCMC operates with a conflict of interest when it serves as an IRO in reviewing Cigna appeals.. Defendants continued reliance on Cigna s internal policy to deny coverage for TMS therapy based on its E/I Exclusion is particularly egregious given that in a number of external appeals relating to TMS coverage, IRO s other than MCMC have frequently made independent determinations that TMS does not fall within experimental and investigational exclusions, but is generally accepted in the mental health community as safe and effective. Defendants are fully aware of these holdings in support of TMS therapy, but choose to ignore them.. According to public records of appeals to IROs regulated by the California Department of Insurance and the California Department of Managed Health Care, since there have been at least reversals of TMS denials by insurers on the basis of an E/I Exclusion.. For example, in, two IRO physician reviewers overturned an insurer s denial of TMS on the basis of an E/I Exclusion: [I]t is worth noting that TMS has been reported to be free of complications associated with anesthesia, cardiac risks, and memory disturbances as 00.

25 Case :-cv-00 Document Filed 0/0/ Page of Page ID #: reported with electroconvulsive therapy (ECT) in the treatment of depression and has a mild side effect profile. All told, the use of TMS for the treatment of MDD was scientifically established and in widespread use prior to this patient s start of TMS therapy. Therefore, the therapy at issue was and is likely to be more beneficial for treatment of the patient s medical condition than any available standard therapy.. In another case, two IRO physician reviewers concluded that TMS is widely practiced throughout the U.S., has been granted a category I CPT code by the American Medical Association (AMA), and is FDA approved for patients with treatment-resistant major depressive disorder. Consistent with this support, the requested TMS therapy will likely be more beneficial for treatment of the patient s medical condition than any available modality for this patient s depression. 0. In yet another case, two physician reviewers for an IRO similarly reversed the insurer s denial of coverage for TMS, stating: The body of evidence in the peer-reviewed literature provides adequate support for the efficacy of TMS therapy for the treatment of major depressive disorder. It is a well-tolerated procedure and carries less risk and fewer barriers when compared to electroconvulsive therapy (ECT). Further, and most compelling in support of its application, TMS is endorsed by the American Psychiatric Association in its current clinical practice guideline for the treatment of individuals with depression.. In a appeal, three physician reviewers representing an IRO rejected the insurer s denial of coverage for TMS, concluding: TMS is safe, appropriate and consistent with good medical practice. Considering the case in its 00.

26 Case :-cv-00 Document Filed 0/0/ Page of Page ID #: entirety within the context of the most current practice guidelines and relevant peer reviewed literature, repetitive TMS is likely to be more beneficial for treatment of the patient s medical condition than any remaining available standard therapy. CLASS ACTION ALLEGATIONS. Plaintiff Annette Weil brings her claims on her own behalf and on behalf of a Cigna Class, defined as: All participants or beneficiaries in ERISA Plans underwritten or administered by Defendant Cigna (or any of its operating divisions) who, during the relevant limitations period were denied health insurance coverage for TMS provided for the treatment of Major Depressive Disorder on grounds that included the assertion that it was experimental or investigational.. The definition of experimental or investigational services in Cigna s health insurance policies at all relevant times has been or substantially similar to the definition in the Weil Plan.. In addition, Plaintiff brings her claims on her own behalf and on behalf of an MCMC Class, defined as: All participants or beneficiaries in ERISA Plans underwritten or administered by Defendant Cigna (or any of its operating divisions) who, during the relevant limitations period, were denied health insurance coverage for TMS provided for the treatment of Major Depressive Disorder following an external appeal in which MCMC upheld a denial of coverage, on grounds that included the assertion that it was experimental or investigational.. The E/I Exclusion contained in the Weil Plan and relied upon by both Cigna and MCMC in denying coverage for Plaintiff is functionally 00.

27 Case :-cv-00 Document Filed 0/0/ Page of Page ID #: indistinguishable from, and is interpreted by Defendants in the same manner as, comparable exclusions included in the Cigna plans applicable to all Class members.. The Classes meet all requirements of F. R. Civ. P. (a) and (b). In particular: (a) The members of the Classes are so numerous that joinder of all members is impractical. While the precise number of members in these Classes is known only to Defendants, Cigna is the ERISA fiduciary and has issued the policies providing coverage under tens of thousands of employer-sponsored ERISA plans, and TMS therapy has become so widespread that, at a minimum, requests for coverage of this therapy numbering in the thousands must have been submitted to, and robotically denied by, Cigna. Similarly, MCMC is a national IRO that has likely reviewed hundreds of claims for TMS, if not more. The identities of the class members are readily identifiable. Cigna maintains claims databases that record each instance in which it denies coverage for TMS for treatment of Major Depressive Disorder and MCMC maintains records of each of its external reviews, including those relating to requests for coverage for TMS. TMS therapy is described with a discrete set of procedure codes under the Current Procedural Terminology ( CPT ) 00.

28 Case :-cv-00 Document Filed 0/0/ Page of Page ID #: promulgated by the American Medical Association, and depression is likewise described with a discrete set of diagnostic codes under the Diagnostic and Statistical Manual of Mental Disorders ( DSM ). Accordingly, the members of the Classes can be readily and objectively ascertained through use of records maintained by Defendants. (b) There exist issues of fact and law common to all members of each of these Classes, and indeed common to both Classes, the most obvious and important of which is whether TMS therapy is an experimental or investigational service. The facts that determine the answer to this question do not vary among class members. (c) Plaintiff s claims are typical of the claims of the members of both Classes because Defendants based their denial of coverage on a medical policy that Cigna employs and an incomplete research database that MCMC references with respect to all requests for coverage for TMS for treatment of Major Depressive Disorder. (d) Plaintiff will fairly and adequately protect the interests of the members of the Classes, is committed to the vigorous prosecution of this action, has retained counsel competent and experienced in class action litigation and the prosecution of ERISA claims, and has no interests antagonistic to or in conflict with those of the Classes. 00.

29 Case :-cv-00 Document Filed 0/0/ Page of Page ID #: (e) (f) (g) The prosecution of separate actions by individual members of the Classes would create a risk of inconsistent or varying adjudications that could establish incompatible standards of conduct for Defendants. By applying a uniform medical policy and uniformly deficient and woefully outdated rationale for treating TMS therapy services as experimental, investigational or unproven, Defendants have acted and refused to act on grounds that apply generally to the Classes. A class action is superior to other available methods for the fair and efficient adjudication of this controversy because joinder of all members of the Classes is impracticable. Further, because the unpaid benefits denied Class members are small relative to the expense and burden of individual litigation, it would be impossible for the Class members to redress individually the harm done to them. COUNT I CLAIM FOR VIOLATION OF FIDUCIARY OBLIGATIONS BROUGHT ON BEHALF OF PLAINTIFF AND THE CLASSES. Plaintiff incorporates by reference the preceding paragraphs as though such paragraphs were fully stated herein.. This count is brought pursuant to U.S.C. (a)()(b).. As the entity responsible for making mental health and substance abuse benefit determinations under the Weil Plan and the Cigna Class members 00.

30 Case :-cv-00 Document Filed 0/0/ Page 0 of Page ID #:0 similar plans, and responsible for developing internal practices and policies to facilitate such determinations, Cigna is an ERISA fiduciary. 0. Similarly, as the entity which assumed responsibility for making the final benefit determinations with respect to the Weil Plan and the MCMC Class members similar plans, while serving as an IRO, MCMC is an ERISA fiduciary.. As ERISA fiduciaries, and pursuant to U.S.C. Section 0(a), Cigna and MCMC are required to discharge their duties solely in the interests of the participants and beneficiaries and for the exclusive purpose of providing benefits to participants and their beneficiaries and paying reasonable expenses of administering the plan. They must do so with reasonable care, skill, prudence, and diligence and in accordance with the terms of the plans they administer. They must conform their conduct to a fiduciary duty of loyalty and may not make misrepresentations to their insureds.. Cigna violated these duties by adopting and implementing a policy to deny coverage for TMS based on the experimental and investigational exclusions under its plans, when such a finding was contrary to generally accepted practices and to the terms of the plans. Similarly, MCMC violated these duties by improperly applying the E/I Exclusion to TMS during the course of issuing its final denial through the IRO process. In particular, both Cigna and MCMC ignored current evidence, and widespread acceptance of TMS as a safe and effective 00.

31 Case :-cv-00 Document Filed 0/0/ Page of Page ID #: treatment for depression in improperly applying the E/I Exclusion to TMS. In doing so, Cigna and MCMC did not act solely in the interests of the participants and beneficiaries for the exclusive purpose of providing benefits. They did not utilize the care, skill, prudence, and diligence of a prudent man acting in a similar capacity. They did not act in accordance with the terms of the Weil Plan and other Cigna plans, all of which contain E/I Exclusions.. Instead, Cigna and MCMC elevated their own interests and those of their corporate affiliate above the interests of plan participants and beneficiaries. By adhering to an incorrect and outdated policy with regard to TMS, Cigna artificially decreased the number and value of covered claims thereby benefiting its corporate affiliates at the expense of insureds. By improperly applying the E/I Exclusion to TMS, MCMC artificially decreased the number and value of covered claims thereby benefiting its client Cigna, and by extension, itself.. Plaintiff and the other members of the Classes have been harmed by breaches of fiduciary duty of Cigna and MCMC (with respect to the MCMC Class) because their claims have been subjected improperly to the E/I Exclusion, leading to denials of coverage for TMS, when TMS is actually a Covered Service within the definition of the Cigna plans.. Plaintiff, on her own behalf and on behalf of the Classes, seeks the relief identified below to remedy this claim

32 Case :-cv-00 Document Filed 0/0/ Page of Page ID #: COUNT II CLAIM FOR IMPROPER DENIAL OF BENEFITS BROUGHT ON BEHALF OF PLAINTIFF AND THE CIGNA TMS CLASS. Plaintiff incorporates by reference the preceding paragraphs as though such paragraphs were fully stated herein.. This count is brought pursuant to U.S.C. (a)()(b).. Cigna denied the insurance claims for TMS submitted by Plaintiff and other members of the Class in violation of the terms of the Weil Plan and the other Cigna plans that insure members of the Class. Cigna denied these claims based on its E/I Exclusion, which does not properly apply to TMS.. Plaintiff and the members of the Class have been harmed by Cigna s improper benefit denials because they were deprived of insurance benefits they were owed. 0. Plaintiff, on her own behalf and on behalf of the Classes, seeks the relief identified below to remedy this claim. COUNT III CLAIM FOR EQUITABLE RELIEF BROUGHT ON BEHALF OF PLAINTIFF AND THE CLASSES. Plaintiff incorporates by reference the preceding paragraphs as though such paragraphs were fully stated herein. 00.

33 Case :-cv-00 Document Filed 0/0/ Page of Page ID #:. This count is brought pursuant to U.S.C. (a)()(a) only to the extent that the Court finds that the injunctive relief sought to remedy Counts I and/or II are unavailable pursuant to U.S.C. (a)()(b). Plaintiff and the Class have been harmed, and are likely to be harmed in the future, by the breaches of fiduciary duty of Cigna and MCMC described above.. In order to remedy these harms, Plaintiff and the Class are entitled to enjoin these acts and practices pursuant to U.S.C. (a)()(a). COUNT IV CLAIM FOR OTHER APPROPRIATE EQUITABLE RELIEF BROUGHT ON BEHALF OF PLAINTIFF AND THE CLASSES. Plaintiff incorporates by reference the preceding paragraphs as though such paragraphs were fully stated herein.. This count is brought pursuant to U.S.C. (a)()(b) only to the extent that the Court finds that the equitable relief sought to remedy Counts I and II are unavailable pursuant to U.S.C. (a)()(b).. Plaintiff and the Class have been harmed, and are likely to be harmed in the future, by the breaches of fiduciary duty of Cigna and MCMC described above.. Additionally, by engaging in this misconduct, Cigna was unjustly enriched in two ways: first, with regard to fully-insured plans or plans that include 00.

34 Case :-cv-00 Document Filed 0/0/ Page of Page ID #: a stop-loss provision requiring Cigna to pay all benefits above a certain threshold, it avoided paying benefits out of its own funds and/or the funds of its corporate affiliates; second, with regard to other self-funded plans, Cigna charged its corporate customers fees for serving as claims administrator while improperly denying TMS benefits based on the inapplicable E/I Exclusion and also lowered costs for its corporate customers, allowing Cigna to retain current customers and expand its business to new customers.. Similarly, MCMC was unjustly enriched by charging fees for serving as an IRO and by maintaining and/or expanding its business with Cigna and by improperly denying benefits based on the application of the inapplicable E/I Exclusion to TMS.. In order to remedy these harms, Plaintiff and the Class are entitled to appropriate equitable relief, including an appropriate monetary award based on restitution, disgorgement or surcharge, pursuant to U.S.C. (a)()(b). PRAYER FOR RELIEF WHEREFORE, Plaintiff demands judgment in her favor against Defendants as follows: A. Certifying the Classes, as set forth in this Complaint, and appointing Plaintiff as Class Representative; 00.

35 Case :-cv-00 Document Filed 0/0/ Page of Page ID #: B. Declaring that Cigna violated the ERISA Plans, and awarding appropriate benefits; C. Ordering Cigna to make payment, with interest, of unpaid benefits to Plaintiff and all Cigna Class members; D. Permanently enjoining Defendants from treating TMS therapy services as experimental or investigational when provided to treat clinical depression; E. Declaring that Defendants violated the Weil Plan and the similar Cigna plans of the other members of both Classes and that Defendants violated their fiduciary duties under ERISA, and awarding appropriate equitable relief including restitution, disgorgement and surcharges; F. Awarding Plaintiff disbursements and expenses of this action, including reasonable attorneys fees, in amounts to be determined by the Court; and G. Granting such other and further relief as is just and proper. // // // // // 00.